Smart Finder

FDA 510(k) K203509 · Ims Giotto S.P.A.

Substantially Equivalent

510(k) numberK203509

Submission

Device name
Smart Finder
Applicant
Ims Giotto S.P.A.
Sasso Marconi, IT
Received
November 30, 2020
Decision date
July 14, 2021
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IZH – System, X-Ray, Mammographic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1710
Specialty
Radiology

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K122836Affirm Breast Biopsy Guidance SystemIZH · Special Lorad, A Hologic Co.01/11/2013SE
K113607Biopsy Digit S Biopsy SLIZH · Traditional Giotto USA, LLC08/10/2012SE
K113284Biopsy PositionerIZH · Traditional Fuji Film Medical Systems03/07/2012SE

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Questions and answers

When was Smart Finder cleared by the FDA?

Smart Finder (K203509) received a 510(k) decision of Substantially Equivalent on July 14, 2021, 226 days after the submission was received.

What is the product code of K203509?

The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.